Effect of Goal-directed Fluid Therapy on Postoperative Complications

Completed

• Conditions: Liver Diseases; Pancreas Disease
• Interventions: Device: EV1000 platform

• Registration Number: NCT03169998
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

* It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods.

* Laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of GDFT to laparoscopic surgery so far.

* To this end, this study aims to apply the intraoperative GDFT protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

• Laparoscopic hepatobiliary or pancreatic surgery

Exclusion Criteria

• Patients who do not consent to participation in the study
• Pregnant women, breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDFT group	EV1000 platform	The fluid infusion is to be performed, in accordance with GDFT protocol, on the basis of cardiac index (CI), stroke volume index(SVI) and stroke volume (SV) in addition to invasively measured arterial pressure by Vigilio / FloTrac Monitor.

Primary Outcome Measures

Name	Time	Method
Deep vein thrombosis	Postoperative 90 day
Myocardiac infarction	Postoperative 90 day
Delirium	Postoperative 90 day
Acute kidney injury	Postoperative 90 day
Sepsis	Postoperative 90 day
Urinary tract infection	Postoperative 90 day
Stroke	Postoperative 90 day
Wound complication	Postoperative 90 day
Death	Postoperative 90 day
Pulmonary complication	Postoperative 90 day

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of